Nov 15 2011
DANVERS, Massachusetts—The first time Robert Dowling, MD, heard the idea for an implantable cardiac assist device that would be designed to promote heart recovery or remodeling with the intent to explant the device later on, he thought it sounded “kind of crazy.” But, after thinking it over, he decided it might not be such a crazy idea after all. Now, eight years later, the device has been unveiled as Symphony from ABIOMED (Danvers, Massachusetts), which Dowling presented Monday at the American Heart Association (AHA; Dallas) Scientific Sessions in Orlando, Florida.
Before ABIOMED became involved, Dowling, an associate professor of surgery at the University of Louisville (Louisville, Kentucky), and his colleagues were developing the device on their own. Because it was such a new concept, they were able to secure more than $6 million in National Institutes of Health grants to support the development, he told Medical Device Daily. The Symphony device is designed to treat chronic patients with moderate heart failure by improving patient hemodynamics, and potentially improving quality of life. The device is designed with the primary goal of stabilizing the progression of heart failure and/or recovering/remodeling the heart. Prior to this, no current implantable cardiac assist device had been designed for heart recovery or remodeling, ABIOMED said.
The small, minimally invasive device is remotely implanted and requires a simple “pacemaker” pocket insertion, avoiding a sternotomy, ABIOMED noted. It is
designed to recover and/or remodel the patient’s heart muscle with the intent to explant the device after extended support at home. Because it is such an innovative concept, Dowling says, the most commonly asked question he hears after giving a presentation on Symphony is “so, how does it work exactly?”
“We just make a little incision,” Dowling said, adding that it is identical to a pacemaker incision and there is a membrane within the pump that goes up and down. “When the membrane goes up, the pump fills, and when the membrane goes down, the pump ejects,” he said. That makes it easier for the heart to eject, allowing the organ to work more efficiently. In other words, it decreases LV work, increases cardiac output, increases coronary and systemaic blood flow, and decreases filling pressure. The device also beats when the heart rests, he noted.
“Every beat makes it easier for the heart to eject, while the heart’s resting [the device] is pumping,” he explained. The device output is 3.0 L/minute at 100 beats per minute. ABIOMED notes that the device is designed to offer the following potential benefits for heart failure patients: cost-effective solution to improve patient hemodynamics; alleviate heart failure and angina symptoms; and to preserve end-organ function.
“The biggest benefit, I think, is that we can insert it in a half-hour, a very limited operation in terms of trauma to the patient and time in the operating room,” Dowling said. This will ideally allow the device to be offered to patients earlier in their disease progression. “We really think this is going to dramatically improve the quality of life for those patients and expand the number of patients we can help with this kinder, gentler procedure,” Dowling told MDD.
According to ABIOMED, the device’s simple design enables physicians to implant the device with a single graft to the subclavian artery remotely from the heart. A small pocket under the skin to hold the device is made using the same incision. The Symphony is synchronized to the heart through subcutaneous electrocardiogram leads and provides an output of 3.0 L/min at 100 beats a minute and is designed to potentially: reduce the afterload, decreasing the work of the left ventricle; increase the cardiac output and mean arterial pressure; and increase the coronary and systemic blood flow.
Symphony is designed to be a cost-effective alternative for New York Heart Association Class III patients who are not amenable to revascularization, do not respond to inotropes and/or cardiac resynchronization therapies, and continue to experience poor quality of life with frequent hospital admissions. Additionally, these patients maintain all future options such as medications, adjunctive therapies (pharma, stem cell) as well as heart transplantation or implantable left ventricular assist devices. The company also noted that the device will cost less than conventional implantable LVADs. The minimally invasive implantation should lead to a shorter length of stay before the patient is discharged home.
To date, the device has been studied in more than 90 cows. Some of the cows were in heart failure to prove the device is effective while others were healthy just to prove it was safe, Dowling said. “This is size-neutral, gender-neutral, it’s safe, about the same size of an ICD,” and it will fit “any adult and even
medium-to-large sized children if we ever get to that point,”Dowling said.
By AMANDA PEDERSEN
Medical Device Daily